MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number VICMO12.1

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The reporter indicated the surgeon implanted an icl implantable collamer lens, into the patient's left eye (os).The lens was reported as having rotated and the patients pressure had spiked.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional data: b5: the reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -15.00 diopter, in the patients left eye (os) on (b)(6) 2021.The lens was removed on (b)(6) 2022 due to lens rotation not associated to a low vault and elevated intraocular pressure (iop).The patient was "burped" several days in a row and the iop was normal.The lens was repositioned on (b)(6) 2022 but the problem was not resolved and the lens was removed.The eye is foggy but is slightly improved.The cause of the event was patient related factor and the device did not fail to perform.The patient is seeing a glaucoma specialist which was no disclosed to the facility.The patient suffered a ciliary body injury which caused the vision to change and her iop to become uncontrollable.A iol rotation was performed but due to the rotation her pressures began to spike.It was decided to remove the lens for patient safety.The patient is currently seeking glaucoma treatment and there are no plans to replace the lens.H6: health impact- clinical code: 4581 - "burping the pressure." corrected data: d2: common device name: phakic intraocular lens, product code: mta.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15713915
• MDR Text Key: 306913907
• Report Number: 2023826-2022-03878
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female